Drug Approval

Zydus and RK Pharma Partner on Innovative Sterile Injectable for Oncology Supportive Care

Zydus Lifesciences Ltd. (including its subsidiaries and affiliates), a global innovation-driven healthcare company, announced that it has entered into an e...

 November 27, 2025 | News

Accord BioPharma Gains FDA Approval for Two Denosumab Biosimilars to Expand Access to Osteoporosis and Cancer Related Bone Care

Products will treat osteoporosis and skeletal-related events from certain types of bone cancer, expanding the company's biosimilar portfolio Accord BioPha...

 November 21, 2025 | News

Vaxcellbio’s CSO Outlines How DDS Enabled Nanobodies Could Redefine Global Treatment Pathways

Vaxcellbio is betting on the combined power of nanobodies and advanced drug delivery science to push boundaries across ophthalmology and other chronic dise...

 November 20, 2025 | Interaction

AbbVie Secures Approval for EPKINLY in Combination With R2 as the First Bispecific Therapy for Relapsed or Refractory Follicular Lymphoma

   EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is now the first and only bispecific antibody combination therapy available f...

 November 19, 2025 | News

Shanghai Henlius and Organon Achieve FDA Approval for POHERDY, First Pertuzumab Biosimilar in the US

Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN)  announced that the US Food and Drug Administration (FDA) has approved the Biologics...

 November 19, 2025 | News

Lundbeck Moves Closer to Asian Launch of Vyepti with New Drug Application Accepted in Japan

Lundbeck's new drug application (NDA) for Vyepti® (eptinezumab) accepted by Japan's Ministry of Health, Labor and Welfare (MHLW), mark...

 November 17, 2025 | News

Lupin Launches Risperidone Long Acting Injectable in the United States with PrecisionSphere Technology

Global pharma major Lupin announced the launch of Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 5...

 November 17, 2025 | News

EirGenix and Sandoz Sign USD 152 Million Global Deal for Pertuzumab Biosimilar

EirGenix Inc. announced that it has entered into a second global exclusive licensing agreement with international biosimilar leader Sandoz AG (SIX:SDZ/OTCQ...

 November 13, 2025 | News

Mabwell Secures NMPA Approval to Begin Phase II Trial of First-in-Class Anti-IL-11 Antibody for Pathological Scarring

Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that its novel anti‑IL‑11 monoclonal antibody...

 November 12, 2025 | News

Sanyou Bio and Yugong Bio Forge Strategic Alliance to Advance High-End Synthetic Molecular Enzymes

Sanyou Bio and Yugong Bio today announced the signing of a strategic cooperation agreement. This powerful alliance marks a significant step ...

 November 12, 2025 | News

BioDlink and Lepu Biopharma Achieve China Approval for First-in-Class EGFR-Targeted ADC in Nasopharyngeal Carcinoma

BioDlink helps Lepu Biopharma win China's marketing approval for EGFR-targeted ADC treating recurrent or metastatic nasopharyngeal carcinoma T...

 November 06, 2025 | News

Kazia Therapeutics Seeks FDA Guidance on Paxalisib Survival Data in Glioblastoma Under Project FrontRunner Framework

Kazia Therapeutics Limited ("Kazia" or the "Company")announced its intention to request and hold a follow-up Type C meeting with the U.S. Food & Drug A...

 October 28, 2025 | News

Singapore Approves Pfizer-BioNTech’s LP.8.1-Adapted COVID-19 Vaccine for Individuals Aged Six Months and Older

The updated COVID-19 vaccine is expected to be available in Singapore at selected polyclinics and private general practitioner (GP) clinic...

 October 27, 2025 | News

METiS TechBio’s AI-Designed MTS-004 Meets Phase III Success in China, Targeting Pseudobulbar Affect

MTS-004 Poised to Fill an Unmet Need in the Treatment of Pseudobulbar Affect (PBA) METiS TechBio, a global leader in AI-driven nanodelivery and formulatio...

 October 24, 2025 | News


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